Zydus Lifesciences has received final approval from the US Food and Drug Administration (FDA) to market Empagliflozin and Metformin Hydrochloride Tablets in the strengths of 5 mg/500 mg, 5 mg/1000 mg, 12.5 mg/500 mg, and 12.5 mg/1000 mg (US RLD: Synjardy), a company statement notified.
Empagliflozin and Metformin Hydrochloride tablets are used with proper diet and exercise to improve glycemic control in adults with type-II diabetes mellitus. They are also used to lower the risk of cardiovascular death in patients with type-II diabetes mellitus and established cardiovascular disease. The drug will be manufactured at the group’s formulation facility at SEZ, Ahmedabad, India, the statement added.